The Impact of Surgical Complications on Obstetricians' and Gynecologists' Wellbeing and Coping Mechanisms as Second Victims.

BACKGROUND: Obstetric and gynecological (OBGYN) surgery is becoming increasingly complex due to an aging population with increasing rates of medical comorbidities and obesity. Complications are therefore common, and impact not only the patient but can also cause distress to the OBGYN surgeon as a "second victim". OBJECTIVE: The objective of our study was to describe and quantify the range of impacts of complications on OBGYN surgeons and assess sociodemographic, clinician and practice factors associated with such impact. STUDY DESIGN: A cross-sectional survey was developed based on interviews with OBGYNs and a review of the literature. The survey assessed OBGYN's demographic, clinical and practice characteristics, estimated number of complications per year, distress, physical and mental health, sleep, relationship impact caused by complications, and explored strategies OBGYNs used to cope with complications. Univariate logistic regression analyses were used to determine the association between OBGYNs characteristics, and complication consequences. RESULTS: Overall, of 727 survey respondents, 431 (61%) were female, 384 (55%) were 50 years or older, almost half had worked as OBGYN for 15 years or more (329 (45%)), and 527 (73%) usually complete fewer than 10 surgical procedures per week. Most (568 (78%)) reported fewer than three surgical complications per year, and most (472 (66%)) thought this was similar or less than their colleagues. Complications caused most stress when they resulted in poor patient outcomes (653 (90%)), had severe patient consequences (630 (87%)) or were a result of surgeon error (627 (86%)). Complications impacted the majority of OBGYN's wellbeing and sleep. A greater proportion of those younger than 50 years old reported that their mental wellbeing (32(10%), p=0.002) and sleep (130(42%), p=0.03) were affected when a complication occurred. Females were also more likely to report that their physical health (14(3%), p=<0.001), mental health (39(9%), p=0.01) and sleep (183(43%), p=<0.001) were affected. Current trainees (11(10%)) and surgeons with less than 15 years of experience (25(9%)) were more likely to experience mental wellbeing consequences when compared to surgeons of ≥15 years experience (12(4%))(p=0.01). Females reported less willingness to interact with colleagues when complications occurred (323(75%), p=0.006) and surgeons with less than 15 years of training were less likely to report comfort in talking (221(74%), p=0.03) and interacting with others (212(74%), p=0.02). CONCLUSION: The vast majority of OBGYN experience major impact on their health and wellbeing when one of their patients develops a complication. The degree and type of impact reported is similar to those experienced by other surgical specialties. Future studies are needed that test interventions to alleviate the significant impact and follow OBGYNs longitudinally to understand how long the impact of complications lasts.

Implementation of Patient-Reported Outcomes in a Medical Oncology Setting (the iPROMOS Study): Type II Hybrid Implementation Study.

BACKGROUND: Clinical trials have demonstrated that patient-reported outcome measures (PROMs) can improve mortality and morbidity outcomes when used in clinical practice. OBJECTIVE: This study aimed to prospectively investigate the implementation of PROMs in routine oncology. Outcomes measured included improved symptom detection, clinical response to symptom information, and health service outcomes. METHODS: Two of 12 eligible clinics were randomized to implement symptom PROMs in a medical oncology outpatient department in Australia. Randomization was carried out at the clinic level. Patients in control clinics continued with usual care; those in intervention clinics completed a symptom PROM at presentation. This was a pilot study investigating symptom detection, using binary logistic models, and clinical response to PROMs investigated using multiple regression models. RESULTS: A total of 461 patient encounters were included, consisting of 242 encounters in the control and 222 in the intervention condition. Patients in these clinics most commonly had head and neck, lung, prostate, breast, or colorectal cancer and were seen in the clinic for surveillance and oral or systemic treatments for curative, metastatic, or palliative cancer care pathways. Compared with control encounters, the proportion of symptoms detected increased in intervention encounters (odds ratio 1.05, 95% CI 0.99-1.11; P=.08). The odds of receiving supportive care, demonstrated by nonroutine allied health review, increased in the intervention compared with control encounters (odds ratio 3.54, 95% CI 1.26-9.90; P=.02). CONCLUSIONS: Implementation of PROMs in routine care did not significantly improve symptom detection but increased the likelihood of nonroutine allied health reviews for supportive care. Larger studies are needed to investigate health service outcomes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000398202; https://tinyurl.com/3cxbemy4.

Examining labelling guidelines for AI-based software as a medical device: A review and analysis of dermatology mobile applications in Australia.

In recent years, there has been a surge in the development of AI-based Software as a Medical Device (SaMD), particularly in visual specialties such as dermatology. In Australia, the Therapeutic Goods Administration (TGA) regulates AI-based SaMD to ensure its safe use. Proper labelling of these devices is crucial to ensure that healthcare professionals and the general public understand how to use them and interpret results accurately. However, guidelines for labelling AI-based SaMD in dermatology are lacking, which may result in products failing to provide essential information about algorithm development and performance metrics. This review examines existing labelling guidelines for AI-based SaMD across visual medical specialties, with a specific focus on dermatology. Common recommendations for labelling are identified and applied to currently available dermatology AI-based SaMD mobile applications to determine usage of these labels. Of the 21 AI-based SaMD mobile applications identified, none fully comply with common labelling recommendations. Results highlight the need for standardized labelling guidelines. Ensuring transparency and accessibility of information is essential for the safe integration of AI into health care and preventing potential risks associated with inaccurate clinical decisions.

Minimum labelling requirements for dermatology artificial intelligence-based Software as Medical Device (SaMD): A consensus statement.

BACKGROUND/OBJECTIVES: Artificial intelligence (AI) holds remarkable potential to improve care delivery in dermatology. End users (health professionals and general public) of AI-based Software as Medical Devices (SaMD) require relevant labelling information to ensure that these devices can be used appropriately. Currently, there are no clear minimum labelling requirements for dermatology AI-based SaMDs. METHODS: Common labelling recommendations for AI-based SaMD identified in a recent literature review were evaluated by an Australian expert panel in digital health and dermatology via a modified Delphi consensus process. A nine-point Likert scale was used to indicate importance of 10 items, and voting was conducted to determine the specific characteristics to include for some items. Consensus was achieved when more than 75% of the experts agreed that inclusion of information was necessary. RESULTS: There was robust consensus supporting inclusion of all proposed items as minimum labelling requirements; indication for use, intended user, training and test data sets, algorithm design, image processing techniques, clinical validation, performance metrics, limitations, updates and adverse events. Nearly all suggested characteristics of the labelling items received endorsement, except for some characteristics related to performance metrics. Moreover, there was consensus that uniform labelling criteria should apply across all AI categories and risk classes set out by the Therapeutic Goods Administration. CONCLUSIONS: This study provides critical evidence for setting labelling standards by the Therapeutic Goods Administration to safeguard patients, health professionals, consumers, industry, and regulatory bodies from AI-based dermatology SaMDs that do not currently provide adequate information about how they were developed and tested.

Feasibility and safety of a surgical training program in total laparoscopic hysterectomy: Results of a pilot trial.

BACKGROUND: It is widely accepted total laparoscopic hysterectomy (TLH) and vaginal hysterectomy are less invasive procedures compared to total abdominal hysterectomy (TAH). However, rates of TAH remain unreasonably high. AIM: To pilot-test a model of training for practising obstetricians and gynaecologists (O&Gs) in TLH. MATERIALS AND METHODS: Training of participating O&Gs was conducted across four hospitals in Queensland, Australia, while other O&Gs were observed as contemporary controls. Type of hysterectomy, details of the surgery, including adverse events, were collected from hospital medical records. RESULTS: Eleven O&Gs completed the pre-intervention and intervention training periods, and nine completed the post-intervention follow-up. TLH rates increased from 24% prior to 75% during and 68% after intervention. Overall, the uptake rate of TLH showed a two-fold increase during the intervention period (2.08, 95% CI: 1.16-8.56, P < 0.001) and a 12% increase was retained during the follow-up period (1.12, 95% CI: 0.54-4.02, P = 0.427). Pre-intervention, across all sites, 24% of hysterectomies were performed via TAH by the participating specialist trainees, which decreased to 13% during the intervention and 14% during follow-up. The rate of adverse events decreased from 13.5% at pre-intervention, to 6.4% during and 4.2% post-intervention. By comparison, no change in surgical approach or rate of adverse events was observed in the control group. CONCLUSIONS: The implementation of a formal and structured surgical training program teaching TLH resulted in important benefits to trainees, patients and society in the four trial hospitals.

Anticipatory anxiety and participation in cancer screening. A systematic review.

OBJECTIVES: To synthesize current evidence on the association between anticipatory anxiety, defined as apprehension-specific negative affect that may be experienced when exposed to potential threat or uncertainty, and cancer screening to better inform strategies to maximize participation rates. METHODS: Searches related to cancer screening and anxiety were conducted in seven electronic databases (APA PsycINFO, Scopus, Web of Science, Embase, Cochrane Library, PubMed, CINAHL), with potentially eligible papers screened in Covidence. Data extraction was conducted independently by multiple authors. Barriers to cancer screening for any type of cancer and relationships tested between anticipatory anxiety and cancer screening and intention were categorized and compared according to the form and target of anxiety and cancer types. RESULTS: A total of 74 articles (nparticipants  = 119,990) were included, reporting 103 relationships tested between anticipatory anxiety and cancer screening and 13 instances where anticipatory anxiety was reported as a barrier to screening. Anticipatory anxiety related to a possible cancer diagnosis was often associated with increased screening, while general anxiety showed no consistent relationship. Negative relationships were often found between anxiety about the screening procedure and cancer screening. CONCLUSION: Anticipatory anxiety about a cancer diagnosis may promote screening participation, whereas a fear of the screening procedure could be a barrier. Public health messaging and primary prevention practitioners should acknowledge the appropriate risk of cancer, while engendering screening confidence and highlighting the safety and comfort of screening tests.

Understanding how comprehensive geriatric assessment works: the importance of varied methodological approaches.

Comprehensive geriatric assessment (CGA) is the gold standard model of care for older adults with frailty. However, despite a large number of published clinical trials, there remain many unanswered questions about how CGA works in different circumstances. This uncertainty stems from CGA being a deeply complex intervention that is heavily modified by context. This review describes recent and novel methodological approaches that explore the active ingredients of CGA and their interaction with context. Future research should continue to embrace broad methodologies that can help us better understand this intervention, in such a way that it can be implemented with fidelity and associated with positive outcomes for older adults.

Consumer perceptions on privacy and confidentiality in dermatology for 3D total-body imaging.

As 3D total-body photography for the early detection of melanoma is not yet widely used in clinical practice, we do not have a full understanding of patient's concerns about use, privacy and confidentiality, and if their concerns differ depending on the use-case. We conducted a virtual consumer forum to assess patients concerns about privacy and confidentiality in dermatology imaging for research, artificial intelligence development and for their own clinical care.

Informing a position statement on the use of artificial intelligence in dermatology in Australia.

Artificial Intelligence (AI) is the ability for computers to simulate human intelligence. In dermatology, there is substantial interest in using AI to identify skin lesions from images. Due to increasing research and interest in the use of AI, the Australasian College of Dermatologists has developed a position statement to inform its members of appropriate use of AI. This article presents the ACD Position Statement on the use of AI in dermatology, and provides explanatory information that was used to inform the development of this statement.

Patterns and cost of care according to keratinocyte cancer risk stratification in a volunteer population screening clinic: Real-world data from the TRoPICS study.

BACKGROUND: Risk prediction tools have been developed for keratinocyte cancers (KCs) to effectively categorize individuals with different levels of skin cancer burden. Few have been clinically validated nor routinely used in clinical settings. OBJECTIVES: To assess whether risk prediction tool categories associate with interventions including chemoprophylaxis for skin cancer, and health-care costs in a dermatologist-run screening clinic. METHODS: Adult participants who presented to a walk-in screening facility were invited to participate. A self-completed KC risk prediction tool was used to classify participants into one of the five risk categories. Participants subsequently underwent full skin examination by a dermatologist. Dermatological interventions and skin cancer-related medical prescriptions were documented. Total health-care costs, both to the health-care system and patients were evaluated. RESULTS: Of the 507 participants recruited, 5-fluorouracil cream and nicotinamide were more frequently prescribed in the higher risk groups as chemoprophylaxis (p < 0.005). A significant association with high predicted risk was also observed in the use of cryotherapy and curettage and cautery (p < 0.05). The average health-care costs associated with a skin check visit increased from $90 ± 37 (standard deviation) in the lowest risk group to $149 ± 97 in the highest risk group (p < 0.0001). CONCLUSIONS: We observed a positive association between higher predicted risk of skin cancer and the prescription of chemoprophylaxis and health-care costs involved with opportunistic community skin cancer screening. A clinical use of risk stratification may be to provide an opportunity for clinicians to discuss skin cancer prevention and chemoprophylaxis with individual patients.

A qualitative analysis of the needs and wishes of people with type 2 diabetes and healthcare professionals for optimal diabetes care.

AIM: Globally, type 2 diabetes care is often fragmented and still organised in a provider-centred way, resulting in suboptimal care for many individuals. As healthcare systems seek to implement digital care innovations, it is timely to reassess stakeholders' priorities to guide the redesign of diabetes care. This study aimed to identify the needs and wishes of people with type 2 diabetes, and specialist and primary care teams regarding optimal diabetes care to explore how to better support people with diabetes in a metropolitan healthcare service in Australia. METHODS: Our project was guided by a Participatory Design approach and this paper reports part of the first step, identification of needs. We conducted four focus groups and 16 interviews (November 2019-January 2020) with 17 adults with type 2 diabetes and seven specialist clinicians from a diabetes outpatient clinic in Brisbane, Australia, and seven primary care professionals from different clinics in Brisbane. Data were analysed using reflexive thematic analysis, building on the Capability, Opportunity, Motivation and Behaviour model. RESULTS: People with diabetes expressed the wish to be equipped, supported and recognised for their efforts in a holistic way, receive personalised care at the right time and improved access to connected services. Healthcare professionals agreed and expressed their own burden regarding their challenging work. Overall, both groups desired holistic, personalised, supportive, proactive and coordinated care pathways. CONCLUSIONS: We conclude that there is an alignment of the perceived needs and wishes for improved diabetes care among key stakeholders, however, important gaps remain in the healthcare system.

Anatomic Distribution of Cherry Angiomas in the General Population.

BACKGROUND: Cherry angiomas are common benign vascular skin lesions of unknown aetiology, found largely on the trunk. However, their exact anatomic distribution besides their truncal predisposition, and how they manifest in the general population, has not been characterised. METHODS: Three-dimensional (3D) total body imaging was obtained from 163 adult participants of a general population cohort study in Brisbane, Australia. Demographic, phenotypic, and sun behaviour characteristics were collected using a standard questionnaire along with history of melanoma and keratinocyte cancers. Cherry angiomas were identified using an automated classification algorithm with a sensitivity of 87% and a specificity of 99%, developed specifically for this study population. RESULTS: The 3D total body images of 163 participants were analysed. Participants had a median age of 57 years and 61% were male. On average, males had more angiomas than females (median of 16 vs. 12) and the number and size of cherry angiomas increased with age. In addition to male sex and age, an increase in angiomas was associated with Caucasian ancestry other than British/Irish only, fair skin colour opposed to medium/olive, having green/hazel eyes compared to blue/grey, and personal history of melanoma. The most common site for cherry angiomas was the front trunk, followed by the back. Interestingly, although males had more angiomas overall, females had more angiomas on the legs. CONCLUSION: Describing the distribution of cherry angiomas by body site is an important step towards further understanding of the aetiology of angiomas. While personal history of melanoma is associated with an increased number of cherry angiomas, whether this association is prognostic, co-occurs with development of melanoma, or is merely fortuitous requires further investigation.

Development of a Checklist Tool to Assess the Quality of Skin Lesion Images Acquired by Consumers Using Sequential Mobile Teledermoscopy.

BACKGROUND: Mobile teledermoscopy is an emerging technology that involves imaging and digitally sending dermoscopic images of skin lesions to a clinician for assessment. High-quality, consistent images are required for accurate telediagnoses when monitoring lesions over time. To date there are no tools to assess the quality of sequential images taken by consumers using mobile teledermoscopy. The purpose of this study was to develop a tool to assess the quality of images acquired by consumers. METHODS: Participants imaged skin lesions that they felt were concerning at baseline, 1-, and 2-months. A checklist to assess the quality of consumer sequential imaging of skin lesions was developed based on the International Skin Imaging Collaboration guidelines. A scale was implemented to grade the quality of the images: 0 (low) to 18 (very high). Intra- and inter-reliability of the checklist was assessed using Bland-Altman analysis. Using this checklist, the consistency with which 85 sets of images were scored by 2 evaluators were compared using Kappa statistics. Items with a low Kappa value <0.4 were removed. RESULTS: After reliability testing, 5 of the items were removed due to low Kappa values (<0.4) and the final checklist included 13 items surveying: lesion selection; image orientation; lighting; field of view; focus and depth of view. Participants had a mean age of 41 years (range 19-73), and 67% were female. Most participants (84%, n = 71/85) were able to select and image the correct lesion over time for both the dermoscopic and overview images. Younger participants (<40 years old) scored significantly higher (8.1 ± 2.1) on the imaging checklist compared to older participants (7.1 ± 2.4; p = 0.037). Participants had most difficulty with consistent image orientation. CONCLUSIONS: This checklist could be used as a triage tool to filter images acquired by consumers prior to telediagnosis evaluation, which would improve the efficiency and accuracy of teledermatology and teledermoscopy processes. It may also be used to provide feedback to the consumers to improve image acquisition over time.

The Additive Value of 3D Total Body Imaging for Sequential Monitoring of Skin Lesions: A Case Series.

BACKGROUND: Timely diagnosis is the cornerstone of melanoma morbidity and mortality reduction. 2D total body photography and dermoscopy are routinely used to assist with early detection of skin malignancies. Polarized 3D total body photography is a novel technique that enables fast image acquisition of almost the entire skin surface. We aimed to determine the added value of 3D total body photography alongside dermoscopy for monitoring cutaneous lesions. METHODS: Lesion images from high-risk individuals were assessed for long-term substantial changes via dermoscopy and 3D total body photography. Three case studies are presented demonstrating how 3D total body photography may enhance lesion analysis alongside traditional dermoscopy. RESULTS: 3D total body photography can assist clinicians by presenting cutaneous lesions in their skin ecosystem, thereby providing additional clinical context and enabling a more holistic assessment to aid dermoscopy interpretation. For lesion cases where previous dermoscopy is unavailable, corresponding 3D images can substitute for baseline dermoscopy. Additionally, 3D total body photography is not susceptible to artificial stretch artefacts. CONCLUSION: 3D total body photography is valuable alongside dermoscopy for monitoring cutaneous lesions. Furthermore, it is capable of surveilling almost the entire skin surface, including areas not traditionally monitored by sequential imaging.

Reproducible Naevus Counts Using 3D Total Body Photography and Convolutional Neural Networks.

BACKGROUND: The number of naevi on a person is the strongest risk factor for melanoma; however, naevus counting is highly variable due to lack of consistent methodology and lack of inter-rater agreement. Machine learning has been shown to be a valuable tool for image classification in dermatology. OBJECTIVES: To test whether automated, reproducible naevus counts are possible through the combination of convolutional neural networks (CNN) and three-dimensional (3D) total body imaging. METHODS: Total body images from a study of naevi in the general population were used for the training (82 subjects, 57,742 lesions) and testing (10 subjects; 4,868 lesions) datasets for the development of a CNN. Lesions were labelled as naevi, or not ("non-naevi"), by a senior dermatologist as the gold standard. Performance of the CNN was assessed using sensitivity, specificity, and Cohen's kappa, and evaluated at the lesion level and person level. RESULTS: Lesion-level analysis comparing the automated counts to the gold standard showed a sensitivity and specificity of 79% (76-83%) and 91% (90-92%), respectively, for lesions ≥2 mm, and 84% (75-91%) and 91% (88-94%) for lesions ≥5 mm. Cohen's kappa was 0.56 (0.53-0.59) indicating moderate agreement for naevi ≥2 mm, and substantial agreement (0.72, 0.63-0.80) for naevi ≥5 mm. For the 10 individuals in the test set, person-level agreement was assessed as categories with 70% agreement between the automated and gold standard counts. Agreement was lower in subjects with numerous seborrhoeic keratoses. CONCLUSION: Automated naevus counts with reasonable agreement to those of an expert clinician are possible through the combination of 3D total body photography and CNNs. Such an algorithm may provide a faster, reproducible method over the traditional in person total body naevus counts.

Consumer Preference and Willingness to Pay for Direct-to-Consumer Mobile Teledermoscopy Services in Australia.

OBJECTIVE: To investigate consumer preference and willingness to pay for mobile teledermoscopy services in Australia. METHODS: Consumers who were taking part in a randomised controlled trial comparing mobile teledermoscopy and skin self-examination were asked to complete a survey which incorporated a discrete choice experiment (DCE) and a contingent valuation question. Responses were used to determine their willingness to pay for mobile teledermoscopy services in Australia and their overall service preferences. RESULTS: The 199 consumers who responded were 71% female and had a mean age of 42 years (range, 18-73). The DCE results showed that consumers prefer a trained medical professional to be involved in their skin cancer screening. Consumers were willing to pay AUD 41 to change from a general practitioner reviewing their lesions in-person to having a dermatologist reviewing the teledermoscopy images. Additionally, they were willing to pay for services that had shorter waiting times, that reduced the time away from their usual activities, and that have higher accuracy and lower likelihood of unnecessary excision of a skin lesion. When asked directly about their willingness to pay for a teledermoscopy service using a contingent valuation question, the majority (73%) of consumers selected the lowest two value brackets of AUD 1-20 or AUD 21-40. CONCLUSION: Consumers are willing to pay out of pocket to access services with attributes such as a dermatologist review, improved accuracy, and fewer excisions.

Review of educational tools for skin self-examination: A qualitative analysis of laypeople's preferences.

ISSUE ADDRESSED: Skin self-examination (SSE) empowers individuals to be aware of their skin and to identify and present to a doctor with any suspicious lesions; however evidence-based, clear guidance for SSE is lacking. METHODS: A new acronym entitled SCAN (Sore, Changing, Abnormal, New) was compiled to help laypeople recognise early signs of skin cancer. This study undertook a qualitative investigation on how well laypeople understand SCAN and other commonly used educational tools (ABCDE, AC, and "ugly duckling"), whether they have a preferred SSE tool, and whether pictorial presentations enhance their understanding. RESULTS: Seven focus groups were conducted with 28 participants (age range 19-78 years), including 6 participants with a previous melanoma diagnosis. Among all the educational tools presented, SCAN was commonly described as the favoured to guide SSE. SCAN was perceived as patient-oriented due to its simplicity and use of easily understood words, while other tools, although perceived as positive in some aspects, were often identified as complex, difficult to understand and aimed towards clinician use. Pictorial presentations were desired as part of an educational tool; however, many also raised their potential disadvantages. CONCLUSION: This was the first study to determine the patient perspective of SCAN and established a diverse range of potential quality indicators for SSE educational tools. SO WHAT?: The findings of this study suggest that current widely used SSE tools may not be the most effective to promote SSE. SCAN may be preferred, as it simplifies SSE by using lay language and is applicable to all skin cancers.

Same goals, different challenges: A systematic review of perspectives of people with diabetes and healthcare professionals on Type 2 diabetes care.

AIMS: To identify the views of people with Type 2 diabetes (PWD) and healthcare professionals (HCP) about diabetes care. METHODS: A systematic review of qualitative studies reporting both groups' views using thematic synthesis frameworked by the eHealth Enhanced Chronic Care Model was conducted. RESULTS: We searched six electronic databases between 2010 and 2020, identified 6999 studies and included 21. Thirty themes were identified with in general complementary views between PWD and HCP. PWD and HCP find lifestyle changes challenging and get frustrated when PWD struggle to achieve it. Good self-management requires a trustful PWD-HCP relationship. Diabetes causes distress and often HCP focus on clinical aspects. They value diabetes education. PWD require broader, tailored, consistent and ongoing information, but HCPs do not have enough time for providing it. There is need for diabetes training for primary HCP. Shared decision making can mitigate PWD's fears. Different sources of social support can influence PWD's ability to self-manage and PWD/HCP suggest online peer groups. PWD/HCP indicate lack of communication and collaboration between HCP. PWD's and HCP's views about quality in diabetes care differ. They believe that comprehensive, multidisciplinary and locally provided care can help to achieve better outcomes. They recognise digital health benefits, with room for personal interaction (PWD) and eHealth literacy improvements (HCP). Evidence-based guidelines are important but can detract from personalised care. CONCLUSION: We hypothesise that including PWD's and HCP's complementary views, multidisciplinary teams and digital tools in the redesign of Type 2 diabetes care can help with overcoming some of the challenges and achieving common goals.

Complete pathological response following levonorgestrel intrauterine device in clinically stage 1 endometrial adenocarcinoma: Results of a randomized clinical trial.

PURPOSE: Intrauterine levonorgestrel (LNG-IUD) is used to treat patients with endometrial adenocarcinoma (EAC) and endometrial hyperplasia with atypia (EHA) but limited evidence is available on its effectiveness. The study determined the extent to which LNG-IUD with or without metformin (M) or weight loss (WL) achieves a pathological complete response (pCR) in patients with EAC or EHA. PATIENTS AND METHODS: This phase II randomized controlled clinical trial enrolled patients with histologically confirmed, clinically stage 1 FIGO grade 1 EAC or EHA; a body mass index > 30 kg/m2; a depth of myometrial invasion of less than 50% on MRI; a serum CA125 ≤ 30 U/mL. All patients received LNG-IUD and were randomized to observation (OBS), M (500 mg orally twice daily), or WL (pooled analysis). The primary outcome measure was the proportion of patients developing a pCR (defined as absence of any evidence of EAC or EHA) after 6 months. RESULTS: From December 2012 to October 2019, 165 patients were enrolled and 154 completed the 6-months follow up. Women had a mean age of 53 years, and a mean BMI of 48 kg/m2. Ninety-six patients were diagnosed with EAC (58%) and 69 patients with EHA (42%). Thirty-five participants were randomized to OBS, 36 to WL and 47 to M (10 patients were withdrawn). After 6 months the rate of pCR was 61% (95% CI 42% to 77%) for OBS, 67% (95% CI 48% to 82%) for WL and 57% (95% CI 41% to 72%) for M. Across the three treatment groups, the pCR was 82% and 43% for EHA and EAC, respectively. CONCLUSION: Complete response rates at 6 months were encouraging for patients with EAC and EHA across the three groups. TRIAL REGISTRATION: U.S. National Library of Medicine, NCT01686126.

The Functional Assessment of Cancer Therapy Eight Dimension (FACT-8D), a Multi-Attribute Utility Instrument Derived From the Cancer-Specific FACT-General (FACT-G) Quality of Life Questionnaire: Development and Australian Value Set.

OBJECTIVES: To develop a cancer-specific multi-attribute utility instrument derived from the Functional Assessment of Cancer Therapy - General (FACT-G) health-related quality of life (HRQL) questionnaire. METHODS: We derived a descriptive system based on a subset of the 27-item FACT-G. Item selection was informed by psychometric analyses of existing FACT-G data (n = 6912) and by patient input (n = 82). We then conducted an online valuation survey, with participants recruited via an Australian general population online panel. A discrete choice experiment (DCE) was used, with attributes being the HRQL dimensions of the descriptive system and survival duration, and 16 choice-pairs per participant. Utility decrements were estimated with conditional logit and mixed logit modeling. RESULTS: Eight HRQL dimensions were included in the descriptive system: pain, fatigue, nausea, sleep, work, social support, sadness, and future health worry; each with 5 levels. Of 1737 panel members who accessed the valuation survey, 1644 (95%) completed 1 or more DCE choice-pairs and were included in analyses. Utility decrements were generally monotonic; within each dimension, poorer HRQL levels generally had larger utility decrements. The largest utility decrements were for the highest levels of pain (-0.40) and nausea (-0.28). The worst health state had a utility of -0.54, considerably worse than dead. CONCLUSIONS: A descriptive system and preference-based scoring approach were developed for the FACT-8D, a new cancer-specific multi-attribute utility instrument derived from the FACT-G. The Australian value set is the first of a series of country-specific value sets planned that can facilitate cost-utility analyses based on items from the FACT-G and related FACIT questionnaires containing FACT-G items.